PLEURX CATHETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2019-09-09 for PLEURX CATHETER manufactured by Carefusion, Inc.

MAUDE Entry Details

Report Number1625685-2019-00104
MDR Report Key8974469
Report SourceHEALTH PROFESSIONAL,LITERATUR
Date Received2019-09-09
Date of Report2019-09-09
Date of Event2019-08-27
Date Mfgr Received2019-08-27
Date Added to Maude2019-09-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactBDX ANNA WEHRHEIM
Manufacturer Street75 N. FAIRVIEW DRIVE
Manufacturer CityVERNON HILLS IL 60061
Manufacturer CountryUS
Manufacturer Postal60061
Manufacturer Phone8015652341
Manufacturer G1CAREFUSION, INC
Manufacturer Street400 EAST FOSTER RD
Manufacturer CityMANNFORD OK 74044
Manufacturer CountryUS
Manufacturer Postal Code74044
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePLEURX CATHETER
Generic NamePERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
Product CodePNG
Date Received2019-09-09
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION, INC
Manufacturer Address400 EAST FOSTER RD MANNFORD OK 74044 US 74044


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Required No Informationntervention 2019-09-09

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